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EC number: 241-659-6 | CAS number: 17675-60-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21-03-2017 to 24-08-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals, Section 4, No. 423, “Acute Oral Toxicity – Acute Toxic
Class Method” adopted 17 December 2001 - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Amidinourea phosphate
- EC Number:
- 241-659-6
- EC Name:
- Amidinourea phosphate
- Cas Number:
- 17675-60-4
- Molecular formula:
- C2H6N4O.xH3O4P
- IUPAC Name:
- diaminomethylideneurea;phosphoric acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 16VL8189
Expiry Date: 03 August 2017
Storage Conditions: room temperature, protected from light
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- WISTAR rats Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Prior to the administration a detailed clinical observation was made of all animals. Only healthy animals were used, and food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
Housing and Feeding Conditions:
Full barrier in an air-conditioned room
Temperature: 22 3 °C
Relative humidity: 55 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Free access to Altromin 1324 maintenance diet for rats and mice
Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals).
The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw
fibre bedding
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Single oral dose at a dose volume of 10 mL/kg body weight.
- Doses:
- 2000 mg/kg body weight and 300 mg/kg body weight
- No. of animals per sex per dose:
- 3 per step, see results
- Control animals:
- no
- Details on study design:
- The starting dose was selected to be 2000 mg/kg body weight. Compound-related mortality was recorded for one animal of step 1. Based on these results and according to the acute toxic class method regime, a second step was performed at a dose of 2000 mg/kg body weight. Compoundrelated mortality was recorded for any animal of step 2. Based on these results and according to the acute toxic class method regime, a third step was performed at a dose of 300 mg/kg body weight. No compound-related mortality was recorded for any animal of step 3. Based on these results and according to the acute toxic class method regime, a fourth step was performed at a dose of 300 mg/kg body weight. No compound-related mortality was recorded for any animal of step 4. Based on these results and according to the acute toxic class method regime, no further testing was required.
The surviving animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
The animals which died spontaneously during the observation period were necropsied directly after onset of death. At the end of the observation period the surviving animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally at a dosage of 250-400 mg/kg bw. All animals were subjected to gross necropsy. All gross pathological changes were recorded but not preserved for possible histopathological evaluation. - Statistics:
- Results were interpreted according to OECD Guideline 423, Annex 2
Results and discussion
- Preliminary study:
- See any other information on results
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks:
- LD50 cut-off (rat): 2000 mg/ kg bw
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item showed mortality and other acute oral toxicity characteristics after a single dose administration of 2000 mg/kg body weight. The test item showed no mortality but other acute oral
toxicity characteristics after a single dose administration of 300 mg/kg body weight. - Clinical signs:
- other: See any other information on results
- Gross pathology:
- See any other information on results
Any other information on results incl. tables
Clinical Signs - Individual Data | ||||
Step | Female No. | Dose (mg/kg bw) | Timepoint | Observations |
1 | 1 | 2000 | 0-60 min | nsf |
60 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure, slight salivation | |||
240 -15 d | nsf | |||
2 | 2000 | 0 -120 min | nsf | |
120 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure, slight salivation | |||
240 - 300 min | Died spontaneously | |||
3 | 2000 | 0 -120 min | nsf | |
120 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure, slight salivation | |||
240 min -15 d | nsf | |||
2 | 4 | 2000 | 0-30 min | Moving the bedding, moderate salivation |
30 - 60 min | Moderately reduced spontaneous activity, moving the bedding, hunched posture, slow movements, slight piloerection, half eyelid closure, slight salivation | |||
60 -120 min | Moderately increased spontaneous activity, hunched posture, slight piloerection, half eyelid closure, slow movements | |||
120 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure | |||
240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, eyes closed, slow movements. Died spontaneously |
|||
5 | 2000 | 0-30 min | Moving the bedding, moderate salivation | |
30 - 60 min | Moving the bedding, moderately reduced spontaneous activity, hunched posture, slow movements, slight piloerection, half eyelid closure, slight salivation | |||
60 -120 min | Moderately reduced spontaneous activity, hunched posture, slow movements, slight piloerection, half eyelid closure | |||
120 -180 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure | |||
180 min | Died spontaneously | |||
6 | 2000 | 0-30 min | Moving the bedding, moderate salivation | |
30 - 60 min | Moving the bedding, moderately reduced spontaneous activity, hunched posture, slow movements, slight piloerection, half eyelid closure, slight salivation | |||
60 -120 min | Moderately reduced spontaneous activity, hunched posture, slow movements, slight piloerection, half eyelid closure | |||
120 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure | |||
240 min | Moderately reduced spontaneous activity, hunched posture, slow movements, moderate piloerection, eyes closed. Died spontaneously |
|||
3 | 7 | 300 | 0-30 min | nsf |
30 - 60 min | Moderately reduced spontaneous activity, prone position, half eyelid closure | |||
60 -120 min | Slightly reduced spontaneous activity, half eyelid closure, slight salivation | |||
120 -180 min | Slightly reduced spontaneous activity, half eyelid closure, moderate piloerection | |||
180 - 240 min | Slightly reduced spontaneous activity, | |||
240 min - 15d | nsf | |||
8 | 300 | 0-30 min | nsf | |
30 - 60 min | Moderately reduced spontaneous activity, prone position, half eyelid closure | |||
60 -120 min | Slightly reduced spontaneous activity, half eyelid closure | |||
120 -180 min | Slightly reduced spontaneous activity, half eyelid closure, moderate piloerection | |||
180 - 240 min | Slightly reduced spontaneous activity | |||
240 min- 15d | nsf | |||
9 | 300 | 0-30 min | nsf | |
30 - 60 min | Moderately reduced spontaneous activity, prone position, half eyelid closure | |||
60 -120 min | Slightly reduced spontaneous activity, half eyelid closure | |||
120 -180 min | Slightly reduced spontaneous activity, half eyelid closure, moderate piloerection | |||
180 - 240 min | Slightly reduced spontaneous activity | |||
240 min-15 d | nsf | |||
4 | 10 | 300 | 0 min - 15 d | nsf |
11 | 300 | 0 min - 15 d | nsf | |
12 | 300 | 0 min - 15 d | nsf | |
d = day; min = minute(s); nsf = no specific findings |
Body Weights (g) & Body Weight Gain % | ||||||
Step | Female No. | Dose (mg/kg bw) | BW (g) | Body weight in comparison to day 1 (%) | ||
Day 1 | Day 8 | Day 15 | 15 | |||
1 | 1 | 2000 | 146 | 166 | 175 | 20 |
2 | 2000 | 146 | Died spontaneously | |||
3 | 2000 | 150 | 165 | 174 | 16 | |
2 | 4 | 2000 | 159 | Died spontaneously | ||
5 | 2000 | 162 | ||||
6 | 2000 | 158 | ||||
3 | 7 | 300 | 140 | 172 | 184 | 31 |
8 | 300 | 140 | 170 | 199 | 42 | |
9 | 300 | 130 | 162 | 182 | 40 | |
4 | 10 | 300 | 142 | 173 | 191 | 35 |
11 | 300 | 140 | 170 | 183 | 31 | |
12 | 300 | 149 | 176 | 174 | 17 | |
Day 1 = day of administration; bw = body weight |
Findings at Necropsy - Individual Data | ||||
Step | Female No. | Starting Dose (mg/kg bw) | Organ | Macroscopic Findings |
1 | 1 | 2000 | - | nsf |
2 | stomach | Test item residues | ||
3 | - | nsf | ||
2 | 4 | stomach | Test item residues | |
5 | ||||
6 | ||||
3 | 7 | 300 | - | nsf |
8 | - | nsf | ||
9 | - | nsf | ||
4 | 10 | - | nsf | |
11 | - | nsf | ||
12 | - | nsf | ||
bw = body weight; nsf = no specific findings |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 cut-off (rat): 2000 mg/ kg bw
- Executive summary:
A single oral application of the test item guanylurea phosphate to female rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity and mortality. The signs of toxicity recovered within up to 1-day post-dose. After this time point no signs of toxicity were visible. A single oral application of the test item guanylurea phosphate to female rats at a dose of 300 mg/kg body weight was associated with signs of toxicity but no mortality. The signs of toxicity recovered within up to 240 minutes post-dose. After this time point no signs of toxicity were visible.
The median lethal dose observed over a period of 14 days is: LD50 cut-off (rat): 2000 mg/ kg bw. According to Annex I of Regulation (EC) 1272/2008 guanylurea phosphate is proposed to be classified into Category 4.
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